art_32__para_2

Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (Text with EEA relevance) · European Union

2. Before making an EHR system available on the market, importers shall ensure that: the manufacturer has drawn up the technical documentation referred to in Article 37 and the EU declaration of conformity; the manufacturer is identified and an authorised representative has been appointed in accordance with Article 31; the EHR system bears the CE marking of conformity referred to in Article 41 after the conformity assessment procedure has been completed; the EHR system is accompanied by the information sheet referred to in Article 38 with clear and complete instructions for use, including for its maintenance, in accessible formats.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-15 · Text as adopted (Official Journal); later amendments are not incorporated in this text.